RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by
OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV
pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II.
Determine the resectability rate with curative intent in patients with unresectable stage
III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and
toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in
terms of response rate, response duration, and overall time to disease progression in these
patients. V. Evaluate the quality of life in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by
cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous
infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic
adenocarcinoma Unresectable locally advanced (stage III) OR Metastatic (stage IV)
Gallbladder or biliary tract cancer allowed No endocrine tumors or lymphoma of the
pancreas No CNS metastases
PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Life expectancy: At least
12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than
3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No
active infection No other serious systemic disorders No other active malignancies within
the past year except curatively treated basal cell skin cancer or carcinoma in situ of the
cervix Must have central venous access device (i.e., Infusaport or PASPORT) Not pregnant
or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for locally advanced or metastatic disease At least 6 months since prior
adjuvant chemotherapy No prior gemcitabine Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: See Disease Characteristics
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute